๐ฌIn plain words
What the trial is, and whether it could suit you
This clinical trial studies whether a healthy living intervention (HLI), with or without a physical activity intervention (PAI), helps maintain the ability to exercise, heart health, and quality of life in breast cancer patients who are scheduled to receive chemotherapy treatment. Early detection and enhanced therapies for breast cancer have improved 5-year cancer-related survival rates. Unfortunately, many breast cancer survivors are at high risk for long-term exercise intolerance, decreased heart health, and lower quality of life following chemotherapy. Currently, there are no effective therapies to help patients maintain these areas throughout chemotherapy. The HLI in this study includes virtual health education classes, which provide useful information on topics like proper nutrition, managing stress, and sleep practices. This may help patients understand the importance of living a h
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Stage I-III breast cancer (including inflammatory and newly diagnosed, or locally recurrent \[if prior treatment received โฅ 2 years prior\] but not metastatic breast cancer being treated with curative intent). All molecular subtypes (estrogen receptor \[ER\], progesterone receptor \[PR\], human epidermal growth factor receptor 2 \[HER2\], etc.) are acceptable
* Scheduled to receive neoadjuvant or adjuvant cytotoxic chemotherapy. Patient must be enrolled โค 3 weeks from start of cytotoxic chemotherapy
* Age 18 to 85 years at enrollment. The upper age cut-off is due to the increased risk of injury in the older population during the CPET, which uses stationary bicycle exercise testing, outweighing the benefit of including this age group
* Must be able to complete a stationary bicycle exercise test where you pedal against some resistance on a stationary bike with supervisors at your side per patient self-report
* Eastern Cooperative Oncology Group (ECOG) performance status โค 2
* Able to walk at least 2 blocks without chest pain, dyspnea, shortness of breath or fainting per patient self-report
* Able to hold breath for 8 seconds
* Must be able to read and understand English language
* Must have access to a device that allows teleconferencing (e.g., Zoom calls) or be willing to participate in the Tablet Lending Program
* Must be willing to download and use the Trainerize application to their personal device or be willing to participate in the Tablet Lending Program
* Must have a working email address to participate in teleconferencing (e.g., Zoom calls). Local National Cancer Institute Community Oncology Research Program (NCORP) site staff may assist in setting up a new email address, if needed
Exclusion Criteria:
* At enrollment, the following diagnosis and/or conditions may not be present (i.e., documented in the medical record or by patient self-report):
* Symptomatic claustrophobia
* Pregnancy or breast-feeding
* Ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices, such as tissue expanders
* Uncontrolled hypertension (systolic blood pressure \> 190 mm Hg or diastolic blood pressure \> 100 mm Hg)
* Inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion, as determined by the treating physician
* Significant ventricular arrhythmias (\> 20 premature ventricular contractions \[PVCs\]/min)
* Atrial fibrillation with uncontrolled ventricular response (\> 130 beats per minute \[bpm\])
* Unstable or stable angina (cardiac chest pain)
* Severe pulmonary hypertension
* Left main coronary artery disease
* Symptomatic heart failure
* Severe valvular heart disease
* Aortic aneurysm (\> 45 mm diameter) or aortic dissection
* Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise
* Hypertrophic obstructive cardiomyopathy
* Acute myocardial infarction within 28 days of enrollment
* Acute pulmonary embolus and/or deep vein thrombosis within 24 weeks prior to enrollment
* Plans to relocate within 6 months of enrollment and unable to participate in study procedures
* May not be on a simultaneous interventional supportive care (non-therapeutic) clinical trial
* May not be undergoing simultaneous treatment for a concurrent second primary cancer (patients with historical cancer will not be excluded if chemotherapy was received โฅ 2 years prior)
* May not be currently engaged in โฅ 300 minutes of moderate to vigorous intensity physical activity per week as determined by self-report on the International Physical Activity Questionnaire -Short Form (IPAQ-SF). Site should use the IPAQ-SF screener in the REDCap WF-2401 STEPS-BC screening project to assist in this determination
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What it tests
- Exercise Intervention
- Educational Intervention
- Supportive Care
- Biospecimen Collection
- Magnetic Resonance Imaging
Wake Forest NCORP RB
Winston-Salem, United States
Wake Forest NCORP Research Base
Winston-Salem, United States
VCU Massey Cancer Center at Stony Point
Richmond, United States
VCU Massey Comprehensive Cancer Center
Richmond, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.